RecruitingPhase 1Phase 2NCT05842785

TSN222 in Subjects With Advanced Solid Tumors or Lymphomas

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of TSN222 in Subjects With Advanced Solid Tumors or Lymphoma


Sponsor

Tyligand Bioscience (Shanghai) Limited

Enrollment

162 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study is a first-in-human \[FIH\], open-label phase 1/2 study of TSN222 in subjects with advanced solid tumors or lymphomas. This study is comprised of a Phase 1 dose escalation and Phase 2 dose expansion component.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1/2 study testing TSN222, a new investigational drug, in people with advanced solid tumors (cancers in organs) or lymphomas that have not responded to standard treatments. The study first determines the safest and most effective dose, then assesses how well it works. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor or lymphoma with no good remaining standard treatment options - Your cancer has at least one measurable tumor visible on scans - You are in relatively good health (able to carry out normal daily activity with at most mild limitations) - Your life expectancy is at least 3 months and you are willing to provide tumor tissue samples **You may NOT be eligible if...** - You have active, untreated, or unstable brain metastases (cancer spread to the brain) - You have serious autoimmune disease, uncontrolled infection, or significant organ dysfunction - You are pregnant or breastfeeding - You have been treated with other investigational drugs very recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhase I dose escalation

The eligible subjects will receive TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

DRUGPhase II-HNSCC

The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

DRUGPhase II-Advanced melanoma

The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

DRUGPhase II-solid tumors or lymphomas

The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.


Locations(1)

Fudan Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT05842785